Recall record at a glance
| Official record | Z-0222-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medical Components, Inc dba MedComp |
| Report date | Nov 6, 2019 |
| Recall initiation date | Oct 1, 2018 |
| Quantity | 24 |
| Location | Harleysville, PA, United States |
Official product description
C3 Wave App, v. 2.0.5
Why the product was recalled
When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.
Distribution information
Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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